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Observational Study of Corneal Opacities in Adults

Sponsor
Oregon Health and Science University (Other)
Overall Status
Recruiting
CT.gov ID
NCT02109471
Collaborator
National Eye Institute (NEI) (NIH)
150
Enrollment
1
Location
150
Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A prospective observational study on corneal opacities (scar and stromal dystrophy) in adults (n=150) will be conducted at OHSU. The Optovue anterior segment OCT will be used to perform 3-D corneal scans. These scans will be used to assess opacity depth and measure corneal thickness (pachymetry), corneal topography (anterior and posterior), and epithelial thickness maps. The ultrahigh-speed MIT OCT prototypes will also be used when they become available. A comprehensive eye examination, Placido-ring corneal topography, ultrasound pachymetry, and Scheimpflug camera imaging, will be performed for comparison.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    150 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Observational Study of Corneal Opacities in Adults
    Study Start Date :
    Jun 1, 2011
    Anticipated Primary Completion Date :
    Dec 1, 2023
    Anticipated Study Completion Date :
    Dec 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    corneal opacities

    Outcome Measures

    Primary Outcome Measures

    1. Identification of suitable subjects [2 years]

      The primary goal of this observational study is to identify suitable subjects for the clinical trials of OCT-guided transepithelial PTK.

    Secondary Outcome Measures

    1. Validate OCT topography [2 years]

      A second goal is to validate OCT anterior topography by comparison with standard Placido-ring corneal topography and develop a mathematical model that relates epithelial thickness variation to corneal mean curvature.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Adult (18 & older) patients presenting in OHSU Casey Eye Clinic with corneal opacities (scar and stromal dystrophy)

    Exclusion Criteria:

    • Inability to give informed consent.

    • Inability to maintain stable fixation for OCT imaging.

    • Inability to commit to required visits to complete the study.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Humberto Martinez Portland Oregon United States 97239

    Sponsors and Collaborators

    • Oregon Health and Science University
    • National Eye Institute (NEI)

    Investigators

    • Principal Investigator: David Huang, MD, PhD, Oregon Health and Science University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    David Huang, David Huang, MD, PhD, Professor of Ophthalmology, Oregon Health and Science University, Oregon Health and Science University
    ClinicalTrials.gov Identifier:
    NCT02109471
    Other Study ID Numbers:
    • OHSU IRB#6612 - Opac
    • R01EY018184
    First Posted:
    Apr 10, 2014
    Last Update Posted:
    Jul 15, 2021
    Last Verified:
    Jul 1, 2021
    Keywords provided by David Huang, David Huang, MD, PhD, Professor of Ophthalmology, Oregon Health and Science University, Oregon Health and Science University
    corneal opacities
    Optical coherence tomography
    Additional relevant MeSH terms:
    Corneal Opacity

    Study Results

    No Results Posted as of Jul 15, 2021